目的 探討安替可膠囊聯合TP方案（紫杉醇＋順鉑）治療晚期食管鱗癌的臨床療效。方法 選取2019年1月—2022年1月河南省人民醫(yī)院收治的100例術后復發(fā)轉移、晚期轉移無法手術治療的晚期食管鱗癌患者，將所有患者隨機分為對照組（50例）和治療組（50例）。對照組第1天靜脈滴注紫杉醇注射液135 mg/m²，第1～3天靜脈滴注順鉑注射液75 mg/m²。治療組于對照組基礎上口服安替可膠囊，2粒/次，3次/d。3周為1個治療周期，兩組患者持續(xù)治療3個周期。觀察兩組的臨床療效，比較兩組腫瘤標志物[鱗狀細胞癌抗原（SCC-Ag）、細胞角蛋白19片段（CYFRA21-1）、癌胚抗原（CEA）、糖類抗原125（CA125）]、細胞免疫功能淋巴細胞（CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺）、生存質量（QLQ-C30評分、KPS評分）以及不良反應、隨訪1年的生存情況。結果 治療后，治療組客觀緩解率（42.00%）、疾病控制率（74.00%）明顯高于對照組（22.00%、52.00%），組間比較差異有顯著性（P＜0.05）。治療后，兩組QLQ-C30評分、KPS評分均顯著升高（P＜0.05），治療組QLQ-C30評分、KPS評分顯著高于對照組（P＜0.05）。治療后，對照組CD3⁺、CD4⁺、CD4⁺/CD8⁺顯著降低，CD8⁺顯著升高（P＜0.05）；治療組CD3⁺、CD4⁺、CD4⁺/CD8⁺明顯高于對照組，CD8⁺低于對照組（P＜0.05）。治療后，兩組血清SCC-Ag、CYFRA21-1、CEA、CA125水平均顯著降低（P＜0.05），治療組血清SCC-Ag、CYFRA21-1、CEA、CA125水平顯著低于對照組（P＜0.05）。治療組不良反應發(fā)生率為28.00%，明顯低于對照組不良反應發(fā)生率48.00%，組間比較差異有顯著性（P＜0.05）。隨訪1年后，治療組中位生存期、腫瘤無進展時間均明顯長于對照組（P＜0.05）。結論 安替可膠囊聯合TP方案治療晚期食管鱗癌能增強治療效果，提高生活質量，減輕免疫功能抑制，降低腫瘤標志物水平，有助于延長患者生存期。

Objective To investigate the clinical efficacy of Antike Capsules combined with TP chemotherapy regimen (paclitaxel + cisplatin) in treatment of advanced esophageal squamous cell carcinoma. Methods Patients (100 cases) with advanced esophageal squamous cell carcinoma patients with recurrence, metastasis, and advanced metastasis that cannot be treated surgically in Henan Provincial People’s Hospital from January 2019 to January 2022 were randomly divided into control and treatment groups, and each group had 50 cases. Patients in the control group were iv administered with Paclitaxel Injection at 135 mg/m²on the first day, and patients in the control group were iv administered with Cisplatin Injection at 75 mg/m²from first to third day. Patients in the treatment group were po administered with Antike Capsules on the basis of the control group, 2 grains/time, three times daily. Three weeks was one treatment course, and patients in two groups continued to be treated for three courses. After treatment, the clinical efficacies were evaluated, and tumor markers (SCC-Ag, CYFRA21-1, CEA, and CA125), cellular immune function [lymphocytes (CD3⁺, CD4⁺, CD8⁺, and CD4⁺/CD8⁺], quality of life (QLQ-C30 score and KPS score), 1-year follow-up survival and adverse reactions were compared between two groups. Results After treatment, the objective response rate (42.00%) and disease control rate (74.00%) of the treatment group were significantly higher than those of the control group (22.00%, 52.00%), with significant differences between two groups (P < 0.05). After treatment, QLQ-C30 score and KPS score of two groups were significantly increased (P < 0.05), and QLQ-C30 score and KPS score of the treatment group was significantly higher than those of the control group (P < 0.05). After treatment, CD3⁺, CD4⁺, CD4⁺/CD8⁺ in the control group were significantly reduced, while CD8⁺ in the control group was significantly increased (P <0.05). CD3⁺, CD4⁺, CD4⁺/CD8⁺ in the treatment group were significantly higher than those in the control group, while CD8⁺ in the treatment group was lower than that in the control group (P < 0.05). After treatment, the serum levels of SCC-Ag, CYFRA21-1, CEA, and CA125 in two groups were significantly reduced (P < 0.05), the serum levels of SCC-Ag, CYFRA21-1, CEA, and CA125 in the treatment group were significantly lower than those in the control group (P < 0.05). The incidence of adverse reactions in the treatment group was 28.00%, significantly lower than 48.00% in the control group, and there was a significant difference between two groups (P < 0.05). After 1 year of follow-up, the median survival time and tumor progression free time in the treatment group were significantly longer than those in the control group (P <0.05). Conclusion Antike Capsules combined with TP chemotherapy regimen in treatment of advanced esophageal squamous cell carcinoma can enhance the therapeutic effect, improve quality of life, alleviate immune suppression, reduce tumor marker levels, and help prolong patient survival period.

R979.1

河南省科技攻關項目(212102310693)